India sounds alert over counterfeit Defitelio

India has issued an urgent regulatory alert in response to a counterfeit batch of Defitelio, a life-saving intravenous drug used to treat severe hepatic veno-occlusive disease (VOD) following hematopoietic stem-cell transplantation. The World Health Organization (WHO) alerted the market surveillance and control regulation and safety department, noting that a suspected falsified medicinal product was being sold in India.

This alert, issued on October 23, highlights cartons labeled "DEFITELIO (defibrotide) 80 mg/mL concentrate for solution for infusion" with batch number 24GC01A and an expiry date of April 2027. These counterfeit products falsely attribute Patheon's Ferentino, Italy facility and Gentium S.r.l., a subsidiary of Jazz Pharmaceuticals, as the manufacturer and marketing authorization holder, respectively.

The Central Drugs Standard Control Organization (CDSCO) has confirmed that the manufacturer never supplied this batch to India. After receiving a request from India to verify the authenticity of a specific pack, Gentium S.r.l. discovered the packaging contained counterfeit DEFITELIO. Using this evidence, European regulators and the drugmaker concluded the packaging was fraudulent.

The DCGI has directed field enforcement officers, zonal directorates, and port health officers to maintain vigilance on the drug's movement, sale, distribution, and stock in the market. They must also draw samples and take appropriate action as per the Drugs and Cosmetics Act, 1940. Doctors and hospitals are urged to report any adverse events, while consumers must verify purchase documents.

The AIOCD has been tasked with alerting pharmacy networks and halting sales of the counterfeit drug immediately. Experts emphasize that promptly alerting the public can help patients access drugs more safely.